Aidoc scored a second FDA 510(k) clearance last month for artificial intelligence software aimed at finding and triaging potential brain aneurysms in CT scans.
According to the FDA's database, the agency gave the green light on the tool around the same time in March as it did Aidoc's algorithm for flagging pneumothorax, or a collapsed lung, on X-rays. That clearance was announced last week. ...
Radiology artificial intelligence company Aidoc scored FDA 510(k) clearance for its tool for flagging and triaging cases of pneumothorax, or a collapsed lung, on X-rays.
Aidoc said the software could run on all X-rays, including portable machines, and automatically notes positive cases of pneumothorax so physicians can focus on these images more quickly.
Some of Aidoc's other FDA-cleared tools...
With hundreds of thousands of health apps on the market today, choosing the right one can be confusing for patients. Countries all over the world are looking to help their citizens navigate the process. Governments are increasingly moving towards a centralized approach for digital health regulation and reimbursement, according to a new article in Nature.
"We found that most approaches aim for...
Cionic scored FDA 510(k) clearance for its Neural Sleeve, a legging that provides electrical stimulation so people with foot drop and muscle weakness can walk more easily.
The leg-worn device, which officially received the green light from the agency in mid-February, is aimed at people with neurological conditions like multiple sclerosis, stroke and cerebral palsy. The sleeve's electrical...
French imaging AI company GLEAMER scored FDA 510(k) clearance for its software designed to identify fractures in X-rays.
BoneView uses artificial intelligence to detect potential fractures and sends results to radiologists for confirmation. The software received a CE mark in Europe in March 2020.
"In the value-based U.S. healthcare system, providers tell us they want to improve the radiographic...
Artificial intelligence care coordination company Viz.ai landed an FDA 510(k) clearance for its new algorithm designed to detect cerebral aneurysms. Dubbed Viz Aneurysm, the technology was designed to pinpoint the condition from CT scans.
The new algorithm will fit into Viz Intelligent Care Coordination Platform, and be used to help streamline getting detected aneurysm into the clinical workflow...
Abbott's implantable cardiac sensor system CardioMEMS landed an expanded FDA clearance, allowing earlier stage heart failure patients to use the tech.
The system, which is designed to monitor pressure changes in the heart, is implanted in a patient's pulmonary artery during a minimally invasive procedure. The connected sensor is able to send data daily to doctors and care teams about a patient's...
Continuous glucose monitoring system maker Senseonics has won FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months.
The system works using a sensor that is implanted just under the skin by a healthcare provider. A transmitter worn over the sensor, on top of the skin, receives glucose data, provides vibratory alerts and...
AliveCor is rolling out a new credit-card-size personal ECG called the KardiaMobile Card. The technology, which landed FDA clearance in November, is able to take a single-lead ECG in 30 seconds.
The Bluetooth-backed technology is able to pair with a smartphone and detect six types of arrhythmias including; AFIB, Bradycardia, Tachycardia, PVCs, Sinus Rhythm with SVE and Sinus Rhythm with Wide QRS...
Insulin pump-maker Insulet has scored FDA 510(k) clearance for its Omnipod 5 Automated Insulin Delivery System for people ages 6 and up with Type 1 diabetes. The pump integrates with the Dexcom G6 continuous glucose monitor to automatically adjust insulin levels depending on blood glucose. It can be worn for up to 72 hours.
Users can control their pump and share data from an app if they have a...
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